Pfizer Inc. (PFE) recently received a boost with the U.S. Food and Drug Administration’s (:FDA) Arthritis Advisory Committee voting 8-2 in favor of the company’s rheumatoid arthritis candidate, tofacitinib.
Pfizer is looking to get tofacitinib approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
While the FDA is not required to follow the advice of its advisory panels, it usually does so. A response on the approval status of tofacitinib should be out by August 2012.
FDA approval would make tofacitinib the first new oral disease-modifying antirheumatic drug (DMAR) to be approved for rheumatoid arthritis in more than 10 years. Moreover, tofacitinib would be the first Janus kinase (:JAK) inhibitor to be approved for rheumatoid arthritis. Pfizer is also seeking approval for tofacitinib in several other regions including the E.U. and Japan.
Tofacitinib is one of the most promising candidates in Pfizer’s pipeline. Last year, the company had presented encouraging data on tofacitinib from a phase III study.
Tofacitinib met its primary endpoint in the ORAL Sync phase III study (A3921046), which was conducted with patients suffering from moderate-to-severe rheumatoid arthritis. Results showed that compared to placebo, tofacitinib achieved a statistically significant reduction in signs and symptoms of rheumatoid arthritis.
Being an oral treatment, tofacitinib could have an edge over existing therapies which need to be injected or administered through infusion. The rheumatoid arthritis market currently has players like products like Abbott’s (ABT) Humira and Johnson & Johnson’s (JNJ) Remicade and Simponi among others.
We currently have a Neutral recommendation on Pfizer, which carries a Zacks #3 Rank (short-term Hold rating).
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